Aminolevulinic acid solution followed by exposure to a certain type of light (blue light using the BLU–U Blue Light Photodynamic Therapy Illuminator) treats the skin condition called actinic keratoses.
Aminolevulinic acid gel is used in combination with the medical device BF-RhodoLED® for PDT treatment of mild to moderate actinic keratoses on the face and scalp.
Aminolevulinic acid gel is to be given only by a health care provider.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of aminolevulinic acid in the pediatric population. Safety and efficacy have not been established. St
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aminolevulinic acid in the elderly.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Aminolevulinic acid gel:
You will receive this medicine in a clinic or doctor's office. A nurse or other caregiver will apply the medicine.
If you are using the aminolevulinic acid solution:
If you are using the aminolevulinic acidgel:
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
If your condition does not improve within 3 months , or if it become worse, check with your doctor.
Using Ameluz® with BF-RhodoLED® lamp may cause eye irritation or injury. It may also cause swelling of the eyelids. Tell your doctor right away if you have blurred vision, changes in vision, or red, sore eyes after receiving this medicine.
After aminolevulinic acid application, avoid exposure to sunlight or bright indoor light (eg, from examination lamps, operating room lamps, tanning beds, or being close to lights) up until the time of the blue or red light treatment. Wide-brimmed hats or similar head covering can help protect you from sunlight or sources of light. Sunscreens will not protect you from sunlight or sources of light.
Reduce your exposure to light if you experience stinging or burning on the treated areas before blue light treatment.
During the blue light treatment you will experience sensations of tingling, stinging, prickling or burning of the treated skin. These feelings of discomfort should improve at the end of the light treatment.
Following treatment, the actinic keratoses and possibly the surrounding skin will redden and swelling and scaling may also occur. These changes are temporary and should completely resolve by 4 weeks after treatment.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.